In the healthcare setting, an adverse event may be described generally, as a situation involving harm or potential harm to a patient or an adverse reaction of a patient to care provided. An adverse event may include an adverse reaction to a drug or combination of drugs, an adverse drug event, a drug-to-drug interaction, a medication error, a side effect of a drug or drugs, a medical error, or other non-drug related events. An adverse event may also be linked to medical devices employed in patient care.
Regulatory bodies, government and non-government organizations, as well as manufacturers are interested in adverse events for the purpose of ongoing tracking, surveillance or research. Certain types of adverse events, if reported, are reported on a voluntary basis by patients, caregivers, and/or clinicians via a paper based form system. A clinician, upon identification of an adverse event, voluntarily fills out an adverse event form and submits the form to the proper regulatory agency, or other interested parties. Such a system has historically been found to produce reporting rates of less than ten percent due to several possible factors including the difficulty in identifying the occurrence of an adverse event, the hindrance on busy medical personnel's time and workflow, and the lack of value to medical personnel in reporting.